4.3 Bovine Ephemeral Fever vaccine

4 Final decisions on proposed amendments to the current Poisons Standard under regulation 2ZCZU

4.3 Final decision in relation to Bovine Ephemeral Fever vaccine

Final decision

Pursuant to regulation 42ZCZU of the Regulations, a Delegate of the Secretary has made a final decision to amend the current Poisons Standard in relation to bovine ephemeral fever vaccine as follows:

Materials considered

In making this final decision, the Delegate considered the following material:

• The application to amend the current Poisons Standard with respect to bovine ephemeral fever vaccine;
• Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse of a substance;
• The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
• The Scheduling handbook: Guidance for amending the Poisons Standard.

Reasons for the final decision (including findings on material questions of fact)

In determining, that this matter will be a delegate-only decision I have taken into account the information provided in the application from the Applicant (APVMA), and the matters outlined under Section 52E of the Therapeutic Goods Act 1989 and the Scheduling Policy Framework (2018). In particular I note that:

• The proposed amendment to the Poisons Standard entry is to exempt from scheduling the bovine ephemeral fever (BEF) vaccine used for treatment of bovine ephemeral fever in beef and dairy cattle. The regulator (APVMA) has concluded that the human health risk posed by bovine ephemeral fever live vaccines is acceptable according to the criteria stipulated in Section 5A of the Agricultural and Veterinary Chemicals Code Act (1994)(52E(1)(a)).
• The purpose and extent for which the substance is to be used has been adequately outlined by Applicant (52E(1)(b)).
• Safety concerns may arise during preparation, administration and storage of the vaccine. The risks that may arise during vaccine reconstitution of the vaccine are comparable with that of unscheduled vaccines for cattle, and risks arising during administration can be managed through the provision of appropriate training programs for rural resellers by manufacturers. A number of other live-virus vaccines for use in animals are currently unscheduled, and present similar risk to the BEF vaccine (52E(1)(c)).
• Producers have safely administered approximately 180,000 doses of the BEF vaccine. There are no known reports of vaccine interactions in treated animals that would require the monitoring or intervention of a veterinarian. Between 2009 and 2019, human adverse events reported to the APVMA include four incidences of accidental exposure, either needle-stick or squirting towards the face, with no documentation of toxicity (52E(1)(c)).
• There is also no evidence of communal harm from the BEF Vaccine. The APVMA considers, that based on the data, no foreseeable communal harm from the use of this product is likely (52E(1)(c)).
• The dosage, formulation, labelling, packaging and presentation of the product under consideration will remain unchanged (52E(1)(d)).
• The current BEF live virus vaccine has no ability to produce dependency and no propensity for misuse, abuse or illicit use (52E(1)(e)).

Therefore, based on the information provided in the application, I have decided to amend the current Poisons Standard in the manner set out in the application. The proposed amendment was not referred to an expert advisory committee.

Date of effect of the decision

1 February 2021